The control of bleeding is essential and critical in surgical procedures to minimize blood loss, to reduce post-surgical complications, and to shorten the duration of the surgery in the operating room. Due to its biodegradability and its bactericidal and hemostatic properties, oxidized cellulose, as well as oxidized regenerated cellulose has long been used as a topical hemostatic wound dressing in a variety of surgical procedures, including neurosurgery, abdominal surgery, cardiovascular surgery, thoracic surgery, head and neck surgery, pelvic surgery and skin and subcutaneous tissue procedures. A number of methods forming various types of hemostats based on oxidized cellulose materials are known, made in powder, woven, non-woven, knit, and other forms and combinations thereof. Currently utilized hemostatic wound dressings include knitted or non-woven fabrics comprising oxidized regenerated cellulose (ORC), which is oxidized cellulose with increased homogeneity of the cellulose fiber. Examples of such hemostatic wound dressings commercially available include Surgicel® resorbable hemostat; Surgicel Nu-Knit® resorbable hemostat; and Surgicel® Fibrillar resorbable hemostat; all available from Johnson & Johnson Wound Management Worldwide, a division of Ethicon, Inc., Somerville, N.J., a Johnson & Johnson Company. Other examples of commercial resorbable hemostats containing oxidized cellulose include Oxycel® resorbable cellulose surgical dressing from Becton Dickinson and Company, Morris Plains, N.J.
The commercially available oxidized cellulose hemostats noted above are knitted or non-woven fabrics having a porous structure for providing hemostasis.
U.S. Pat. No. 3,364,200 to Ashton and Moser describes a resorbable, surgical hemostat in the form of pledgets of integrated oxidized cellulose staple fibers. However, there is no suggestion that such pledgets could be used to introduce hemostatic material through a trocar during laparoscopic surgical procedures. The need for very specific properties allowing for hemostatic materials based on cellulose fibers to be introduced into operational space through a trocar or similar device become apparent with the advent and broad spread of the use of the laparoscopic techniques several years after the issuance of the U.S. Pat. No. 3,364,200 in 1968.
Published U.S. Patent Application Publication 2008/0027365 to Huey describes an apparatus for promoting hemostasis utilizing oxidized cellulose in the form of a compressible, shapeable mass that is formed into a sheet for placement on a bleed site and further having a sleeve in a form of a tubular shell dimensioned to receive a limb.
Published U.S. Patent Application Publication 2004/0005350 to Looney et al. discloses hemostatic wound dressings utilizing a fibrous fabric substrate made from carboxylic-oxidized cellulose and containing a porous, polymeric matrix homogeneously distributed through the fabric and made of a biocompatible, water-soluble or water-swellable cellulose polymer, wherein the fabric contains about 3 percent by weight or more of water-soluble oligosaccharides.
Published U.S. Patent Application Publication 2007/0160654 to Ferguson discloses a method for the manufacture of a reinforced gel-forming fabric composite for use as a wound dressing, whereby the gel-forming fiber material in non-woven fabric form is needled into the reinforcing layer from one side so as to penetrate through the reinforcing layer and form a layer of gel-forming fiber material on both sides of the reinforcing layer. The process further involves forming the gel-forming fiber material by non-woven carding, crossfolding of gel-forming fiber, and needling at a needle punch. The teachings of Ferguson are specific to a fibrous material on a supporting layer and to gel-forming materials.
Published U.S. Patent Application Publication 2007/0036943 to Hirose et al. teaches a non-woven absorbent fabric containing crimped fibers, which form a large number of fiber clusters that are distributed all over the first layer, whereby the clusters interconnect to each other to form a network structure in the same first layer. Another fiber layer disposed on a side of the first layer protrudes outwardly between to form a large number of protrusions.
Published U.S. Patent Application Publication 2006/0258995 to Pendharkar et al. teaches a method of making a multilayered fabric comprising a first resorbable nonwoven fabric and one or more a second resorbable woven or knitted fabric. The fabric is specifically multilayered.
Published U.S. Patent Application Publication 2002/0168911 to Tonner discloses an absorbent fleece for use in hospital supplies, comprises a fiber blend of 80-95% viscose and 10% polyester formed into a dry laid, nonwoven web, wherein the web consists of multiple, carded and cross-lapped layers that are consolidated using a needle-punch process, whereby the fleece has a water absorption of at least about 1,000 wt % and an absorbing speed of at least about 20 mm after 10 seconds.
U.S. Pat. No. 7,427,574 to Allen discloses a non-woven washcloth formed from a blend of two different size polyester fibers, the majority of which have a length about half of that of the minority, that are subjected to carding, crosslapping and needle punching to produce a fabric with inter-engaged fibers. The washcloth has good absorbing and holding properties for a solution containing chlorhexidine gluconate, while also releasing said chlorhexidine gluconate when wiped on skin.
U.S. Pat. No. 7,229,689 to Qin et al. discloses a nonwoven, felt wound dressing formed by carding polysaccharide fibers to produce a web, cross lapping said web to form a thick layer of felt, needle punching the felt to form a needled non-woven structure, and slitting said needled non-woven structure to form individual wound dressings. This invention relates to polysaccharide fibers having water absorption properties characterized by the incorporation within the fibers of at least one substance having anti-microbial properties, and to wound dressings formed from said fibers. The polysaccharide fibers are preferably formed from alginate or alginate containing additional polysaccharide materials to give additional absorbency. The fibers preferably contain a silver compound as an antimicrobial agent.
U.S. Pat. No. 6,735,835 to Wong discloses a method of making a non-woven fabric that includes carding and needle punching. A method of manufacturing a non-woven fabric comprising opening and mixing different input fibers to form a uniform fiber mixture having predetermined proportions of the different input fibers; carding the fiber mixture to form a uniform web of predetermined thickness travelling in a first direction; laying onto the web high tenacity yarns which extend in the first direction and are spaced apart transversely of the first direction; depositing fixed lengths of the web in alternating fashion on a conveyor travelling in a second direction transverse to the first direction to form on the conveyor a mat consisting of overlapping lengths of the web; and needle-punching the mat to form the non-woven fabric.
U.S. Pat. No. 5,824,335 to Dorigatti et al. teaches bioresorbable non-woven fabric materials for use in surgery, said materials constituting threads embedded in a matrix, wherein both the matrix and the threads constitute auto-crosslinked hyaluronic acid, with the production of the non-woven surgical fabric that includes carding and needle punching.
U.S. Pat. No. 3,837,338 to Chesky et al. teaches a conformable non-woven bandage comprising a felted cellulosic nonwoven fabric, in which the fibers have substantial freedom of movement relative to each other, is mechanically compacted into a series of undulations, to yield a bandage material that does not decrease in width when elongated by 10% or more.
U.S. Pat. No. 5,503,623 to Tilton teaches instrumentation and method for laparoscopic insertion and application of sheet like surgical material, such as an adhesion barrier, and undertakes to enable the laparoscopic surgeon to utilize large and full size sheets of Interceed™ in abdominal (including pelvic) surgery. In laparoscopy surgery of the abdomen (including pelvis), all instrumentation and all surgical products must be introduced through “ports” consisting of valved sleeves or tubes. To properly and efficiently introduce and apply a large or full size sheet of sheet like material, Tilton provides a method and apparatus of grasping and furling the sheet and then unfurling, releasing and applying it after passage into the patient's abdominal cavity. The instrument consists of an operational grasping and furling portion which is rotated to furl the sheet like material. It is then “backloaded” or drawn into a tubular portion of the instrument, an inserter sheath for passage through the valved “port”. Once the sheet like material is in the abdominal cavity it is unfurled. The grasping portion of the instrument provides for proper and easier alignment and then application of the unfurled sheet. Additional flexibility is achieved by an articulation mechanism which allows horizontal movement of the grasping/furling element to produce an angle in the instrument body.
U.S. Pat. No. 5,957,939 to Heaven, discloses a medical device for deploying surgical fabrics at an operative site within a body cavity of a patient. The device includes a deploying member in the form of an elongated inserter shaft with a supporting member in the form of a sheet of plastic attached to a distal end of the shaft. A sheet of surgical fabric is placed on the supporting member and rolled around the inserter shaft. An introducer tube surrounds the rolled-up fabric and supporting member to prevent them from unrolling. The introducer tube may then be inserted into the body cavity and retracted to allow the supporting member to self-unwind the fabric sheet within the body cavity.